Exploratory Study of the Effects of Lu AA21004 on Cognition and Blood Oxygen Level Dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Signals in Subjects Remitted From Depression and in Controls
This study is currently recruiting participants.
Verified March 2013 by H. Lundbeck A/S
Sponsor:
H. Lundbeck A/S
Information provided by (Responsible Party):
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT01607125
First received: May 24, 2012
Last updated: March 14, 2013
Last verified: March 2013
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Purpose
The purpose of this study is to determine if Lu AA21004 20 mg/day will lead to changes in neural activity (BOLD signal), as measured using fMRI, in brain areas associated with executive functioning and memory during cognitive task performances compared to placebo in subjects remitted from depression and in controls, and to explore if Lu AA21004 will lead to improved cognitive performance in the absence of depression.
| Condition | Intervention | Phase |
|---|---|---|
|
Depression |
Drug: Lu AA21004 Drug: Placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Interventional, Randomised, Double-blind, Parallel-group, Placebo-controlled, Exploratory Study Investigating the Effects of Lu AA21004 on Cognition and BOLD fMRI Signals in Subjects Remitted From Depression and Controls |
Resource links provided by NLM:
Further study details as provided by H. Lundbeck A/S:
Primary Outcome Measures:
- Effect of Lu AA21004 on BOLD signal in fMRI of the brain areas associated with executive function (working memory) [ Time Frame: Day 1 to Day 13 ] [ Designated as safety issue: No ]
- Effect of Lu AA21004 on BOLD signal in fMRI of the brain areas associated with spatial memory [ Time Frame: Day 1 to Day 13 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Effect of Lu AA21004 on cognitive performance (executive function, memory, speed of processing, attention, cognitive flexibility) and emotional processing [ Time Frame: Day 1 to Day 13 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 96 |
| Study Start Date: | July 2012 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Lu AA21004 |
Drug: Lu AA21004
encapsulated 20 mg tablets, orally, once daily for 13 to 14 days
Other Name: Vortioxetine
|
| Placebo Comparator: Placebo |
Drug: Placebo
capsules, orally, once daily for 13 to 14 days
|
Eligibility| Ages Eligible for Study: | 25 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
All subjects must have:
- a Hamilton Depression Rating Scale (HAM-D17) total score ≤ 7
Subjects remitted from depression must:
- be in remission from recurrent depression having suffered from at least two previous Major Depressive Episodes (MDEs)
- have received prescribed treatment with an antidepressant or a recognised psychotherapy for depression for a previous MDE
- report present subjective cognitive dysfunction
- not have been treated with antidepressants or received other psychotherapy for depression for at least six weeks prior to screening visit
Control group subjects must:
- have no history of MDEs
- have no history of MDEs in a biological parent or other first degree relative as reported by the subject
- not report present subjective cognitive dysfunction
- never have been treated with antidepressants or psychotherapy
Exclusion Criteria:
- The subject is, in the opinion of the investigator, unlikely to comply with the clinical study protocol or is unsuitable for any other reason
Other inclusion and exclusion criteria may apply.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01607125
Contacts
| Contact: Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@lundbeck.com |
Locations
| United Kingdom | |
| GB001 | Recruiting |
| Headington, United Kingdom, OX3 7JX | |
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
| Study Director: | Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@lundbeck.com |
More Information
No publications provided
| Responsible Party: | H. Lundbeck A/S |
| ClinicalTrials.gov Identifier: | NCT01607125 History of Changes |
| Other Study ID Numbers: | 14137A, 2011-001839-23 |
| Study First Received: | May 24, 2012 |
| Last Updated: | March 14, 2013 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders |
ClinicalTrials.gov processed this record on June 18, 2013